This is a collaborative proposal (in response to RFA CA-98-028) from the Seattle Consortium for Identification and Development of Biomarkers of Early Neoplasia (SCIDBEN) to establish a Biomarkers Developmental Laboratory (BDL). SCIDBEN consists of researchers at the University of Washington, the Fred Hutchinson Cancer Research Center, several biotechnology companies, Virginia Mason Medical Center, and MD Anderson Cancer Center. These researchers are employing a variety of approaches to development of molecular cancer screening assays including: genomics-based programs for detection of cancer-associated or cancer-specific proteins (Leroy Hood, Peter Nelson, Michael Schummer, Mac Cheever, Steve Reid); detection and quantitation of oxidative DNA damage (Dr. Larry Loeb); detection of abnormal DNA methylation sequences (ORCA); detection of serum antibodies elicited by tumor antigens (Dr. Brad Stone); novel monoclonal antibodies for detection of ovarian cancer (Dr. Ingegerd Hellstrom); and development of high through-put proteome analysis technology (Dr. Aebersold). A number of putative cancer biomarkers are currently awaiting evaluation by the proposed BDL, and others will become available for testing by the BDL over the next five years. Although many markers have been identified and novel technologies for their detection developed, the process has been complicated by the absence of infrastructure that provides access to adequate amounts of well-characterized malignant and benign tissues, and corresponding body fluids. Furthermore, the utility of the candidate biomarkers and novel technologies identified by SCIDBEN researchers remains unknown, since the basic science laboratories are funded for discovery of biomarkers but not for assay development and early phase proof of principle testing . In addition, in many cases, these molecules and technologies have been developed to address a basic scientific question without regard to clinical applicability. Frequently, such laboratories do not have the ability, resources, or the interest to attempt to develop them into clinically appropriate assays. A large number of benign and malignant tissues, blood and other body fluids and corresponding information regarding demographic characteristics, treatment and risk factors, will be available to the BDL. Dr. Kiviat has extensive experience in tissue banking for molecular studies and her research laboratory has the proven ability to develop and validate the required clinical assays and to perform the early phase testing.